Emdogain Implementation With Transcrestal Sinus Lifting and Dental Implant Placement

T.C. Dumlupınar Üniversitesi

Status and phase: Completed; Phase 4

Conditions: Bone Density Increased; Osseointegration Failure of Dental Implant

Treatments: Drug: Enamel Matrix Protein

Study type: Interventional

Funder types: Other

Identifiers

NCT05507047

14/4

Details and patient eligibility

About

The aim of this study is to evaluate the clinical and radiographic results of implants placed using osteotome sinus floor elevation (OSFE) with and without simultaneous enamel matrix derivative (EMD) application.

Full description

Twenty-four patients will be randomly assigned into two groups: Group I: (EMD+OSFE) (n=20 implants, 13 patients) OSFE with EMD application, and Group II 8OSFE): (n=20 implants, 11 patients) OSFE without EMD application. The patients will be recall at 3- and 12- months after surgery. The residual bone height (RBH), implant protrusion length (IPL), peri-implant sinus bone level (SBL), endo-sinus bone gain (ESBG), implant stability and peri-implant bone density values (Hounsfield units) will be assessed.

Enrollment: 24 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• partial edentulism in the maxillary posterior region for at least 4 months from tooth loss and require implant treatment
• adequate bone thickness for primary stabilization
• residual bone height ranged from 4 mm to 6 mm
• systemic and local conditions compatible with implant placement and sinus floor elevation
• antagonist teeth

Exclusion criteria

• uncontrolled diabetes mellitus or other systemic disorders (such as; hepatitis, tuberculosis, AIDS)
• pregnancy
• untreated periodontal disease
• endodontic lesions or other oral disorders
• heavy smokers (≥10 cigarettes per day)
• acute or chronic rhinitis
• sinusitis or pathology in sinus
• inadequate residual bone height and quality to achieve implant stability
• previous implant treatment/failure or bone augmentation in the implant site
• sinus perforation as confirmed via Valsalva maneuver
• insufficient primary implant stability measured by RFA

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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24 participants in 2 patient groups

Transcrestal Sinus Lifting with Emdogain

Experimental group

Description:

Osteotome sinus floor elevation with enamel matrix derivated

Treatment:

Drug: Enamel Matrix Protein

Transcrestal Sinus Lifting

Active Comparator group

Description:

Osteotome sinus floor elevation

Treatment:

Drug: Enamel Matrix Protein